- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT02006368
Assessment of Whole Blood Cold Stored Platelets (Brrr)
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
Subjects will be enrolled for evaluation of platelet recovery and survival. Healthy subjects will be consented and enrolled into the study until 8 subjects have completed the recovery and survival evaluations at 4, 8, 12, 16, and 20 days storage. The order in which storage intervals are evaluated will be randomized. Eight subjects will then be evaluated at the mid-range interval between longest storage period that meets acceptances criteria and shortest storage period that does not meet acceptance criteria. For instance, if at 12 days of storage the 95% lower confidence limits for recoveries are NOT ≥50% of fresh and survivals are LESS than one day, but at 8 days of storage recoveries are ≥50% of fresh and survivals are at least than one day, we will then evaluate 10 days of storage. If the 10 day storage does not meet acceptance criteria we will evaluate 9 days. If the 10 day storage does meet acceptance criteria we will evaluate 11 days. Eight subjects will be evaluated at each storage interval.
Subjects will donate one unit of whole blood. This unit will be maintained as whole blood in CPD (Citrate Phosphate Dextrose anticoagulant) not leukoreduced and not separated into components. These WB units will be stored under refrigerated conditions (4°C) for between 4 and 20 days after collection. Prior to refrigeration samples from the unit will be obtained for various in vitro tests.
In vivo Measurements:
At the end of each subject's storage period a ~200 mL aliquot of whole blood will be withdrawn from the unit. This aliquot will be centrifuged and the platelets extracted. The platelets will be radiolabeled with 51-Cr or 111-In. On that day, the subject will return to the Blood Center and provide a 43 mL fresh blood sample. Platelets from that sample will be harvested and labeled with the other isotope. Radiolabeling will be done by the BEST method. These aliquots will be sequentially infused into the subject. The estimated amount of the isotope is ≤15 μCi of indium and ≤20 μCi of chromium will be infused. The total radiation dose is approximately 40 μCi for a total body absorbed dose of 0.0273 rad (0.273 mSv) and a splenic absorbed dose of 3.2 rad (32 mSv). Venous samples (10 mls/draw) will be taken within 2 hours after reinfusion and on days 1, 2, 3, 5, 7 ± 1, and 10 ± 2. After these visits, the subject's participation will end and they will exit the study. Stored and fresh platelet recoveries and survivals will be determined and comparisons will be made between each subject's fresh and stored platelet recoveries.
In vitro Assays:
The following assays will be performed using a 50 ml sample obtained from the whole blood pre and post storage:
- platelet count
- platelet function assays (mean platelet volume, morphology score, hypotonic shock response, extent of shape change, pH, PO2, PC02, HC03, glucose and lactate. Platelet aggregation response to standard agonists (ADP, collagen, arachidonic acid) will also be measured.
- platelet activation and apoptotic markers (p-selectin antigen, annexin V, platelet microparticles)
- thrombelastograph
- thrombin generation test
- plasma analysis of coagulation, complement, microparticles and fibrinolytic potential (thrombin-antithrombin complex (TAT), plasmin-antiplasmin complex (PAP), soluble cd 40l, plasminogen activator inhibitor (PAI-1 ), complement (C3a, C4d, C5b-9)
- sterility - bacterial cultures will be submitted after collection and the results evaluated 14 days later, or sooner if blood is stored for a shorter time period. A gram stain will be performed on the isolated 4° C platelets before reinfusion at the end of storage. All sterility tests must be negative before test platelets will be reinfused.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
-
-
Washington
-
Seattle, Washington, Spojené státy, 98104
- Puget Sound Blood Center
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
- The subject is in good health, is taking no excluded medications, and satisfies the Blood Center's criteria to donate blood products. Criteria will also include the following guidelines:
- Meets whole blood/platelet donor suitability requirements as defined in 21 CFR 640.3 and set forth by the AABB (Reference Standard 5.4.1A, 2006). Past travel restrictions do not apply for this study.
- Weight ≥50 kg (110 pounds)
- Hemoglobin/hematocrit: ≥12.5 g/dL/38%
- Temperature: less than or equal to 37.5 degrees C
- Resting blood pressure: systolic less than or equal 180 mmHg; diastolic ≥100 mmHg
- Resting heart rate: 50 to 100 beats per minute
- Age ≥ 18 years, of either sex;
- Able to read, understand and sign the informed consent document and commit to the study follow-up schedule;
- Subjects must have good veins for whole blood collection and follow-up blood draws;
- Subjects of child-bearing potential must agree to use an effective contraceptive during the course of the study;
Those subjects who will be reinfused within 10 days of their 500 mL WB collection must meet the criteria for donating a double RBC unit to accommodate the sampling volume that will occur shortly thereafter:
- Male subjects must weigh a minimum of 130 lbs and be at least 5'1" tall
- Female subjects must weigh a minimum of 150 lbs and be at least 5'5" tall
- Both male and female subjects must have a Hematocrit of ≥ 40%;
Exclusion Criteria:
- Any serious medical illness and/or therapy, including: abnormal bleeding episodes, clotting or bleeding disorder, evidence of anemia, myocardial infarction, uncontrolled hypertension, heart disease, surgery with bleeding complications, epilepsy or any major surgery (with general or spinal anesthesia) within the last 6 months;
- Taking aspirin, Alka-Seltzer™, clopidogrel, or other "anti-platelet" drugs within 7 days prior to donation.
- Taking any nonsteroidal anti-inflammatory drug (for example: Motrin™, Advil™, or ibuprofen) within 3 days prior to donation.
- Taking any anticoagulant medications (for example Coumadin, dabigatran, rivaroxaban or any medications chemically related to heparin).
- Currently pregnant or nursing within the 6 weeks prior to enrollment as assessed during interview. Current status is confirmed by pregnancy test prior to radioisotope infusion.
- Inability to comply with the protocol in the opinion of the investigator.
- Participation in another investigational trial that would potentially interfere with the analysis of this investigation (e.g., pharmaceutical);
- Have participated in ≥ 4 research studies involving radioisotopes within the last 12 months.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Základní věda
- Přidělení: N/A
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
---|---|
Experimentální: Storage Age
|
Subjects will donate one unit of whole blood. This unit will be stored at 4°C for a predefined storage period. A variety of in vitro metabolic and functional platelet assays will be performed on the stored unit. After the storage period, an aliquot from the whole blood unit will be processed to obtain platelets. The subject will return and donate a fresh sample of whole blood (43 mls) from which a fresh aliquot of platelets will be obtained. The stored and fresh platelets will each be labeled with a different radioisotope (either Chromium-51 or Indium-111) and reinfused into the subject. Using two different radioisotopes enables separate tracking of both the stored and fresh platelets. Follow-up blood samples will be drawn at 2 hours and on days 1, 2, 3, 5, 7±1 and 10±2. Stored and Fresh platelet recoveries and survivals will be calculated. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
To determine the relationship between each donor's fresh and stored platelet recoveries.
Časové okno: Whole blood units will be held for 4-20 days at 4 degrees C, assigned at consent.
|
The primary endpoint of this study will be to determine the relationship between each donor's fresh and stored platelet recoveries.
The lower 95% confidence limit for the data should be that platelet recoveries at the end of storage should be ≥50% of fresh and survivals should be ≥ 1 day.
|
Whole blood units will be held for 4-20 days at 4 degrees C, assigned at consent.
|
Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Sherrill J Slichter, MD, Puget Sound Blood Center & University of Washington
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další identifikační čísla studie
- 12-10
- W81XWH-12-1-0441, EDMS 5570 (Jiné číslo grantu/financování: DoD)
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
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